TITLE from VIEW and SLIDE MASTER | 26 October 2016 1 |

Evolving role of DTC

including prescribing guidance

Interface Management of Pharmacotherapy Barcelona – 17th October 2016

NICOLA MAGRINI

SECRETARY OF ESSENTIAL MEDICINES LIST ESSENTIAL MEDICINES AND HEALTH PRODUCTS DEPARTMENT

Essential Medicines List: Concept and Procedures 2 |

Essential Medicines

Guiding principle: A limited range of carefully selected medicines leads to better health care, better medicines management, and lower costs

Definition: Essential medicines are those that satisfy the priority health care needs of the population

Selection: Selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness

Essential Medicines List: Concept and Procedures 3 |

A more transparent and evidence-based process (EB109/8 2001)

Essential Medicines List: Concept and Procedures 4 |

EML and DTC

Role of evidence – value of drugs

Link between essential medicines and guidelines

High cost of many new and effective medicines

Essential Medicines List: Concept and Procedures 5 |

EML, DU and guidelines

Important role of evidence in the development of the recommendations

– strong vs weak recommendations (listing/sub-listing, restrictions … – Indicators of and level of use

Guidelines and conflicts of interests

DTC and comprehensive pharmaceutical policy – Strong link/coordination with GLs groups – Tender management groups – One approach and common methodologies

Essential Medicines List: Concept and Procedures 6 |

Essential medicines and guidelines

Important role of evidence in the development of the recommendations

– strong vs weak recommendations (listing/sublisting, restrictions … – Indicators and level of use

Guidelines and conflicts of interests

DTC and comprehensive pharmaceutical policy – Strong link/coordination with GLs groups – Tender management groups

Essential Medicines List: Concept and Procedures 7 |

Tender competencies: a complex task

Tenders need

Technical guidance (from DTC) and feedbacks from prescribers and patients

Administrative and legal support (ad hoc from HS)

Management and policy capacity (ad hoc from HS)

Essential Medicines List: Concept and Procedures 8 |

EML/DTC, GL and … financing

1. Evaluation, evidence synthesis and value

2. Recommendation and planning of expected use

3. Indicators: for monitoring and budget

4. Review it at different level and share all the information with all different stakeholders

financing / affordability / sustainability

Essential Medicines List: Concept and Procedures 9 |

Essential medicines and guidelines

Important role of evidence in the development of the recommendations

– strong vs weak recommendations (listing/sublisting, restrictions … – Indicators and level of use

Guidelines and conflicts of interests

DTC and comprehensive pharmaceutical policy

Pharmaceutical policies • By pharmaceutical policy we mean the conscious efforts of

national governments to influence the pharmaceutical system

Marc J. Roberts and Michael R. Reich. Pharmaceutical Reform.

A Guide to Improving Performance and Equity. World Bank, 2011

Functions of pharmaceutical sector • Registration of medicines • Licensing of pharmaceutical business • Inspection of establishment • Medicine promotion • Clinical trials and independent confirmatory research • Indipendent drug information • National (NHS) guidelines program • Selection of essential medicines • Procurement of medicines • Distribution of medicines • Drug utilization

National level Local level

Access to Essential Medicines| 26 October 2016 12 |

The pharmaceutical market: a highly regulated one

Promotion

Patent

R&D and clinical trials

Manufacturing

Inspection

Distribution

Registration

Selection

Procurement & import

Pricing

Prescription

Dispensing

Pharmacovigilance

Access to Essential Medicines| 26 October 2016 13 |

The pharmaceutical market: inefficiencies and unethical practices can occur

Promotion

Conflict of interest

Pressure

Falsification safety/

efficacy data Bribery

Patent

R&D and clinical trials

Manufacturing

Inspection

Distribution

Registration

Selection

Procurement & import

Pricing

Prescription

Dispensing

Pharmacovigilance

Thefts Over- invoicing

Counterfeit/ substandard

Collusion Unethical donations

Unethical promotion

High prices

Inappropriate forecasting

Inappropriate use

Losses

Access to Essential Medicines| 26 October 2016 14 |

The pharmaceutical market: a highly regulated one

Promotion

Patent

R&D and clinical trials

Manufacturing

Inspection

Distribution

Registration

Selection

Procurement & import

Pricing

Prescription

Dispensing

Pharmacovigilance

Falsification safety/

efficacy data

Collusion Unethical donations

Conflict of interest

Inappropriate forecasting

Inappropriate use

Losses Bribery

Thefts Over- invoicing

Counterfeit/ substandard

Pressure

Unethical promotion

Jama, 11 October 2016

Rawlins - Jama Sept 2016 • Richer countries spend more on health care than poorer ones; and there is a

remarkably close correlation between a country’s gross domestic product and its expenditure on health care, even when public and private resources for health care are combined.

• Cost easy to define – • whereas effectiveness much more complex and disease specific • Even though these techniques provide evidence of effectiveness in specific

conditions, they are of virtually no use to organizations seeking to compare the costs and benefits of treating one condition compared with another. For example, how are payers expected to compare the value of a new treatment for breast cancer with a new treatment for schizophrenia if the benefits are expressed in totally different ways?

• … (QALYs) gained so the clinical benefits of interventions can be compared across disease states.

HIS/EMP | Communications Planning HIS | EMP

Questions? All questions are welcome

As all questions are useful to understand EML role and what I just presented